The use of liraglutide 3.0 mg daily in the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first episode psychosis: results of a pilot randomised double-blind placebo-controlled trial.

Whicher, Clare A; Price, Hermione C; Phiri, Peter; Rathod, Shanaya; Barnard-Kelly, Katharine; Ngianga, Kandala; Thorne, Kerensa; Asher, Carolyn; Peveler, Robert C; McCarthy, Joanne; Holt, Richard Ig

BACKGROUND People with severe mental illness are 2-3 times more likely to be overweight and obese than the general population and this is associated with significant morbidity and premature mortality. This study investigated the feasibility and acceptability of using liraglutide 3.0 mg daily to address this problem. MATERIALS AND METHODS Design Double-blind, randomised, placebo-controlled pilot trial. Setting Mental health centres and primary care within Southern Health NHS Foundation Trust. Participants Adults with schizophrenia, schizoaffective, or first-episode psychosis prescribed antipsychotic medication who were overweight or obese. Intervention Once daily subcutaneous liraglutide or placebo, titrated to 3.0 mg daily, for 6 months. Primary outcome recruitment, consent, retention and adherence. Secondary exploratory outcomes weight, HbA1c and Brief Psychiatric Rating Scale. RESULTS 799 individuals were screened for eligibility. The commonest reasons for exclusion were ineligibility (44%) and inability to make contact (28%). The acceptance rate, as a proportion of all eligible participants, was 12.2%. The commonest stated reason why eligible candidates declined to participate related to the study specific medication and protocol (n= 50). 47 participants were randomised with 79% completing the trial. Participants in the liraglutide arm had lost a mean 5.7±7.9 kg compared with no significant weight change in the placebo group (treatment difference -6.0 kg, p=0.015). BMI, waist circumference and HbA1c reduced in the intervention group. CONCLUSIONS This study supports the need for a larger randomised controlled trial to evaluate use of liraglutide (maximum dose 3.0 mg daily) in the management of obesity in people with severe mental illness. This article is protected by copyright. All rights reserved.